When reporting milestone-based site payment information, themost critical informationto include isexpected versus actual milestones met to date, by site.
According to theGood Clinical Data Management Practices (GCDMP, Chapter: Project Management and Communication), effective reporting must supportoperational and financial decision-makingby presenting performance indicators in a clear, actionable format. Site payments in clinical studies are typically tied to specific milestones such as subject enrollment, visit completion, or data cleaning achievements.
By comparingexpected (planned)versusactual (achieved)milestones per site, the Data Manager providesclinical operations staffwith an accurate view of site progress and payment eligibility. This allows for identification of delayed sites, forecasting of upcoming payments, and early intervention for underperforming centers.
While milestone summaries by month or type (options A and B) may be useful for trend analysis, they lack the operational detail required for financial tracking. Milestone data by patient (option D) is overly granular for site-level payment management.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 6.2 – Data Reporting for Site Performance and Payments
ICH E6 (R2) Good Clinical Practice, Section 5.18.4 – Communication and Monitoring Reports
FDA Guidance for Industry: Oversight of Clinical Investigations – Site Management and Reporting
